Neurologic Physiology After Removal of Therapy (NeuPaRT) (NeuPaRT)

January 28, 2026 updated by: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Neurologic Physiology After Removal of Therapy (NeuPaRT): Pilot Multicentre Feasibility Study

The purpose of this study is to determine when brain function stops compared to when the heart stops by monitoring electrical brain activity in patients who are taken off life support and progress to death in the intensive care unit.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There are many Canadians who need an organ transplant and who will never get one. In the past, people could only be organ donors after being declared brain dead.

The dead donor rule serves this purpose by ensuring that death determination precedes organ retrieval. In Canada, death determination occurs in one of two ways. In neurologic determination of death (NDD), death is declared upon completion of a standardized neurologic assessment that confirms permanent loss of brain activity. In donation after circulatory determination of death (DCDD), death is declared 5 minutes after circulatory arrest. By confirming permanent loss of brain activity, the current NDD process protects donors from suffering and maintains stakeholder trust. In contrast, the current DCDD process assumes, but does not explicitly confirm, permanent loss of brain activity when death is declared 5 minutes after circulatory arrest. While this assumption is rooted in a strong physiologic rationale, lack of compelling evidence regarding cessation of brain activity in humans contributes to ongoing mistrust of the DCDD process among healthcare and public stakeholders.

Study Type

Observational

Enrollment (Estimated)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N1N4
        • Recruiting
        • University of Calgary Foothills Campus
        • Contact:
          • Andreas Kramer
        • Sub-Investigator:
          • Julie Kromm
    • Ontario
      • Kingston, Ontario, Canada, K7L2V7
        • Recruiting
        • Kingston Health Sciences Centre
        • Contact:
          • Gord Boyd
      • London, Ontario, Canada, N6A 5A5
      • Ottawa, Ontario, Canada, K1H8L6
        • Recruiting
        • Ottawa Hospital
        • Contact:
          • Shane English
        • Sub-Investigator:
          • Sonny Dhanani
        • Sub-Investigator:
          • Tadeau Fantaneanu
    • Quebec
      • Montreal, Quebec, Canada, H2X3E4
        • Recruiting
        • Centre hospitalier de l'Université de Montréal,
        • Contact:
          • Michaël Chassé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include all patients admitted to a participating ICU who fulfil all the inclusion criteria and for whom none of the exclusion criteria exist.

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Plan for the withdrawal of life sustaining measures (WLSM)
  3. Attending physician anticipates patient will die within 24 hours of the withdrawal of life sustaining measures
  4. Patient has an indwelling arterial cannula for monitoring blood pressure

Exclusion Criteria:

  1. Brain death or plan for Neurologic Determination of Death (NDD)
  2. Injuries that anatomically preclude the use of neurologic monitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Accrual complete study procedures)
Time Frame: 2022 to 2023
90 patients at all sites and an additional 18 patients at the lead site for specific tests
2022 to 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waveform Data Completeness
Time Frame: 2022-2023
Adequate waveform signal that (i) spans circulatory arrest, (ii) includes data for at least 80% of the planned observation period (from the withdrawal of life sustaining measures to 30 minutes after circulatory arrest [or 5 minutes for confirmed donation after circulatory determination of death (DCDD) donors]), and (iii) has a clearly identifiable time of cessation for each signal.
2022-2023
Time Difference Circulatory Arrest and Cessation of EEG Activity
Time Frame: 2022-2023
Cerebral blood flow velocity in middle cerebral artery (when available), and cessation of event/evoked potentials (LHSC site only). See below for definition of cessation of each signal.
2022-2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Investigators

  • Principal Investigator: Teneille Gofton, MD MSc FRCPC, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Reda 12243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Requests for data sharing should be directed to the principal investigator (Dr. T. Gofton) and will be considered on a case by case basis and with approval from the Western Health Sciences Research Ethics Board. No video will be shared at any time.

IPD Sharing Time Frame

After completion of data analysis (5 years after study initiation August 2022)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Determination of Death

Clinical Trials on electroencephalography (EEG)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe